XTalks

DECEMBER 1, 2021

The country of South Africa has a particularly sophisticated infectious disease monitoring, surveillance and research infrastructure, which is why the country has been at the forefront in both the identification of coronavirus variants as well as COVID-19 vaccine trials. 1.1.529 variant to South Africa and the world.”.

Gene 105

Gene Genome Genomics Genetics 105

Pharmaceutical Technology

OCTOBER 28, 2022

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug. For biosimilars, however, this process is slightly more complex.

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XTalks

AUGUST 18, 2023

Izervay is the only approved treatment for geographic atrophy that has demonstrated a significant decrease in the rate of geographic atrophy progression at the 12-month primary endpoint, based on results from two rigorous Phase III clinical trials. Izervay contains avacincaptad pegol sodium, an effective complement C5 inhibitor.

FDA Approval 52

FDA Approval Drugs Clinical Trials Clinical Trials 52

The Pharma Data

JANUARY 10, 2021

The new year began with a fairly low level of clinical trial news. Arcturus Therapeutics got the FDA go-ahead for its Phase II trial of its COVID-19 vaccine candidate ARCT-021. The trial will enroll 600 participants, with 450 receiving ARCT-021 and 150 receiving placebo. Here’s a look. COVID-19-Related. Non-COVID-19-Related.

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Gene Therapy Trials Gene Clinical Trials 52

The Pharma Data

OCTOBER 25, 2020

mRNA-1273 is currently being studied in a Phase 3 randomized, 1:1 placebo-controlled trial of 30,000 participants at the 100 µg dose level in the U.S. Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. 26, 2020 11:00 UTC. CAMBRIDGE, Mass.–( About Moderna.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Development 52

The Pharma Data

AUGUST 30, 2021

Overall, Leqvio was well-tolerated, with a safety profile similar to placebo and consistent with the overall pooled population from the combined trials 1 – 3. As the first and only small interfering RNA to provide effective and sustained LDL-C reduction, Leqvio helps manage a critical cardiovascular risk factor for ASCVD.

RNA 52

RNA Trials Production Containment 52

The Pharma Data

OCTOBER 28, 2020

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today confirmed that the Ministry of Health, Labour and Welfare of Japan (MHLW) and Takeda Pharmaceutical Co., 29, 2020 06:00 UTC. CAMBRIDGE, Mass.–(

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The Pharma Data

DECEMBER 8, 2020

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the Swiss Federal Government has increased its confirmed order commitment from 4.5 CAMBRIDGE, Mass.–(BUSINESS –(BUSINESS WIRE)–Dec. million to 7.5

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The Pharma Data

DECEMBER 10, 2020

The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. Pending discussions with the FDA, the oral vaccine will enter Phase I trials as a prime and boost, and will be explored to provide a boost to subcutaneous vaccinations.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

The Pharma Data

JULY 18, 2021

Randomized controlled trials assessing the clinical efficacy of VAXNEUVANCE compared to PCV13 have not been conducted. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F individually conjugated to CRM 197 carrier protein. pneumoniae serotypes contained in the vaccine.

Immune Response 52

Immune Response Vaccination Vaccine FDA Approval 52

The Pharma Data

DECEMBER 19, 2020

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the U.S. Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. 20, 2020 02:44 UTC. CAMBRIDGE, Mass.–( –( BUSINESS WIRE )– Moderna, Inc.,

Vaccination 52

Vaccination Vaccine Licensing Licensing 52

The Pharma Data

DECEMBER 18, 2020

The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein. The vaccine was 94.1%

Vaccination 52

Vaccination Vaccine Production Manufacturing 52

The Pharma Data

NOVEMBER 16, 2020

mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from NIAID’s Vaccine Research Center. CAMBRIDGE, Mass.–(BUSINESS –(BUSINESS WIRE)–Nov. 16, 2020– Moderna, Inc. About mRNA-1273. W911QY-20-C-0100.

Vaccination 52

Vaccination Vaccine Containment Pharmacy 52

Pharmaceutical Technology

NOVEMBER 22, 2022

According to CEPI: “Achieving the 100 Days Mission would give the world a fighting chance of containing a future outbreak before it spreads to become a global pandemic.”. Messenger RNA vaccines contain nucleic acids that code for a specific protein, or target antigen, related to a virus or disease.

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The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. Sanofi, Empowering Life.

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Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

NOVEMBER 16, 2020

I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, and the staff at our clinical trial sites who have been on the front lines of the fight against the virus. The Phase 3 COVE trial is a randomized, 1:1 placebo-controlled study testing mRNA-1273 at the 100 µg dose level in 30,000 participants in the U.S.,

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Delveinsight

DECEMBER 13, 2020

The first approved treatment for hepatitis C was a series of protein-based injections called recombinant interferon-alfa (IFNa). Interferons are naturally occurring proteins in the body; recombinant IFNa is the protein-based drug that works to mobilize the body’s natural immune system to fight disease. in January 2019.

Genotype 52

Genotype FDA Approval DNA Drugs 52

The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. Empowering Life. www.sanofi.com.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

Pfizer

AUGUST 15, 2022

Nirmatrelvir is designed to inhibit viral replication at a stage known as proteolysis, which occurs before viral RNA replication. Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. FDA Emergency Use Authorization Statement. 07.27.2022.

Drugs 99

Drugs Vaccination Vaccine In-Vitro 99

Pfizer

JANUARY 27, 2023

Nirmatrelvir is designed to inhibit viral replication at a stage known as proteolysis, which occurs before viral RNA replication. Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus.

Marketing 75

Marketing Production Drugs Licensing 75

Pharmaceutical Technology

FEBRUARY 1, 2023

As an RNA virus, like SARS-CoV-2, RSV is highly prone to mutations. However, specific antibody-resistant mutations have already been documented within the RSV- F protein after prophylactic administration of nirsevimab. This is concerning as nirsevimab was very recently approved in only two regions.

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The Pharma Data

JANUARY 6, 2021

About CureVac CureVac is a global biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing and optimizing the versatile biological molecule for medical purposes. ak (2021-0003E).

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Vaccination Vaccine Development Marketing 52

The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

The Pharma Data

SEPTEMBER 1, 2020

COVID-19 testing solutions that provide healthcare professionals and patients with a quick answer regarding their infection status are critical to contain the community-spread of the COVID-19 virus. Roche has an ongoing clinical trial program evaluating the role of Actemra©/RoActemra© (tocilizumab) in COVID-19 pneumonia.

In-Vitro 52

In-Vitro Antibody Medicine Clinical Trials 52

Drug Discovery World

DECEMBER 26, 2023

Scientists from the Chemistry and Biochemistry Departments at the University of Liverpool and Nanjing Medical School in China discovered a possible way to block proteins that cause metastasis. The open-label, single patient cohort ascending dose trial followed promising preclinical data for LEU011 in a spectrum of solid tumour models.

Development 64

Development Clinical Trials Clinical Trials Drugs 64

XTalks

DECEMBER 13, 2023

Related: Top 30 Pharma Companies in 2023: Statistics and Trends 1) Moderna Compound annual growth rate: 415 percent Moderna, headquartered in Massachusetts, is a prominent biotechnology company specializing in RNA therapeutics, particularly mRNA vaccines. Alpine Immune Sciences has recently announced an augmentation in its R&D investment.

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Genetics Vaccination Vaccine DNA 111

Roots Analysis

AUGUST 31, 2023

Further, the expression of any gene is dependent on the rate at which it is transcribed into mRNA and translated into proteins. There are various regulatory proteins or transcription factors that are responsible for affecting the transcription rate. These genetic switches assist transcription factors in binding to the promoter region.

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Gene Gene Therapy Gene Expression Regulation 40

The Pharma Data

OCTOBER 25, 2021

At 48 weeks, both trials met their primary efficacity endpoint of chance of actors with HIV-1 RNA situations ? The safety and tolerability profile of DOR/ ISL during the trials to date are harmonious with the preliminarily reported Phase 2 studies. Merck Research Laboratories. “

Trials 52

Trials RNA Clinical Trials Clinical Trials 52

Drug Discovery World

AUGUST 10, 2022

And now, with more than 600 CAR T trials recruiting or ongoing, these cells represent a majority of the cellular immunotherapies in development today. To overcome this evasion tactic, the CAR protein was developed to recognise other markers on cancer cells. Exactly three decades later, the first CAR T cell therapy hit the market.

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Manufacturing Gene Genome Genomics 98

XTalks

OCTOBER 26, 2023

The Flu versus COVID-19: Virology and Vaccines SARS-CoV-2 versus Influenza Virology Viruses contain genetic material that can either be RNA or DNA. Both influenza and SARS-CoV-2 have RNA as their genetic material. An RNA genome enables the genetic material to mutate more rapidly. remains the dominant variant.

Vaccination 105

Vaccination Vaccine RNA Manufacturing 105

Pfizer

DECEMBER 13, 2022

Nirmatrelvir is designed to inhibit viral replication at a stage known as proteolysis, which occurs before viral RNA replication. Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. For more information, please visit www.PAXLOVID.com. .

Drugs 110

Drugs Licensing Licensing Production 110

Drug Discovery World

NOVEMBER 30, 2023

This presentation covered three primary drivers for a protein expression model: speed, cost and sustainability. “It The next presentation attended in this track was the keynote presentation, which was given by Kate Smith, PhD, Head of UK Protein & Cell Sciences at GSK. GSK has developed high-throughput mammalian and E.

Antibody 59

Antibody Protein Engineer In-Vivo 59

Drug Discovery World

JANUARY 4, 2023

The researchers used high-dimensional immune profiling and single-cell RNA sequencing to study how the TIME is affected by a variety of immunotherapies. They identified specific immune checkpoint proteins, 41BB and LAG, that were highly expressed in exhausted T cells. . Details of the study .

Immune Response 52

Immune Response Protein Research Antibody 52

Pfizer

DECEMBER 20, 2022

Results from these analyses are consistent with previously disclosed efficacy and safety data for the trials. Nirmatrelvir is designed to inhibit viral replication at a stage known as proteolysis, which occurs before viral RNA replication. Microsomal triglyceride transfer protein inhibitor: lomitapide. Disclosure Notice.

Drugs 69

Drugs Licensing Licensing Containment 69

The Pharma Data

OCTOBER 14, 2020

is a clinical-stage biopharmaceutical company developing novel RNA-modulating drug candidates (designed to be eukaryotic ribosomal selective glycosides) that are formulated to treat rare and ultra-rare premature stop codon diseases. Premature stop codons are point mutations that disrupt protein synthesis from messenger RNA.

Protein 52

Protein RNA Production Genetics 52

The Pharma Data

AUGUST 31, 2021

Over three years ~300,000 patients at high risk of a second cardiovascular event are expected to be treated with inclisiran, a small interfering RNA therapy administered as a 6-monthly maintenance dose ‡ , in the community setting. comments Jules Payne, Chief Executive at HEART UK, the cholesterol charity. Disclaimer.

Containment 52

Containment Production RNA Medicine 52

The Pharma Data

OCTOBER 27, 2020

Molecular Partners, a global leader in the development of DARPin® therapeutics, will be responsible for the conduct of phase 1 & 2 trials that may lead to emergency use approval; Novartis will be responsible for further development, manufacturing, distribution and commercialization.

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Development Protein Manufacturing Medicine 52